Response to study treatment on neuropathic pain defined as a reduction from baseline to Month 6 of at least 30% in the "modified" Brief Pain Inventory-Short Form 3 (BPI-SF3) score of "neuropathic pain at its worst in the last 24 hours"

Change from baseline to Month 6 in the average daily 11-point Numerical Rating Scale (NRS-11) score of "abdominal pain at its worst in the last 24 hours" in subjects with GI symptoms at baseline.

Change from baseline to Month 6 in the number of days with at least one stool of a Bristol Stool Scale (BSS) consistency Type 6 or 7 in subjects with GI symptoms at baseline.

Change from baseline to Month 6 in plasma globotriaosylceramide (Gb3).

108

All

18 Years and older (Adult, Senior)

NCT03425539

ID-069A301

MODIFY

March 30, 2018

August 19, 2019

September 21, 2019

February 7, 2018

February 14, 2018

University of Alabama at BirminghamBirmingham, Alabama, United States

University of California IrvineIrvine, California, United States

University of Florida College of MedicineGainesville, Florida, United States